Phase I Study of Nimotuzumab in Solid Tumours

NCT00369252 | Completed Phase 1

• 1 other identifier: YMB1000-007
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I trial of nimotuzumab that will be conducted in patients with advanced incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and recommended phase II doses of nimotuzumab that can be safely given to patients with advanced and/or metastatic solid tumors.

Conditions

Advanced and/or Metastatic Solid Tumours

Keywords

Nimotuzumab; TheraCIM; H-R3; Solid tumours; EGFR; Monoclonal antibody

Interventions

Nimotuzumab (TheraCIM h-R3) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced and/or metastatic solid tumors, refractory to standard curative therapy, or for which no curative therapy exists.
• Clinically or radiologically documented disease. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral CT scan.
• Archival tumor specimens evaluable for expression of the EGFR (but EGFR positivity is not a requirement for study entry).
• Patients must have tumor lesions accessible for biopsy for correlative studies. In cases where there are medical contraindications to tumor biopsies, exceptions may be made upon discussion with the Principal Investigators.
• Age \> 18 years.
• ECOG performance status of 0,1,2.
• Previous therapy: Previous chemotherapy, hormonal therapy, radiation and/or surgery is permitted with certain restrictions as outlined in the protocol.
• Hematology and chemistry lab results within specifications outlined in the protocol.
• Willingness to give written informed consent.
• Patients must be accessible for treatment and follow-up.
• Protocol treatment is to begin within 2 working days of patient registration.

You may not qualify if:

• Pregnant or lactating women. Both men and women enrolled on study should be using adequate birth control measures throughout the course of the study.
• History of second malignancy who have a disease-free interval of less than two years (except cervical cancer in situ or nonmelanomatous skin cancer).
• Untreated brain or meningeal metastases. Patients with treated and stable brain metastases are eligible providing that they have radiologic evidence of disease stabilisation of at least 3 months duration and are asymptomatic.
• Untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.
• Active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
• Prior therapy with EGFR targeting therapies, including monoclonal antibodies or small molecule tyrosine kinase inhibitors.
• Allergy to the antibody.
• Concurrent treatment with other experimental drugs or anti-cancer therapy.
• Inability or unwillingness to give written, informed consent prior to study participation.

Sponsors & Collaborators

• YM BioSciences: lead
• CIMYM BioSciences: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

nimotuzumab

Study Officials

• Eric Chen, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Lillian Siu, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 25, 2006
• First Posted: August 29, 2006
• Study Start: June 1, 2005
• Last Updated: February 28, 2007

Record last verified: 2007-02

Locations

CA (1)